Chi K N, Kheoh T, Ryan C J, Molina A, Bellmunt J, Vogelzang N J, Rathkopf D E, Fizazi K, Kantoff P W, Li J, Azad A A, Eigl B J, Heng D Y C, Joshua A M, de Bono J S, Scher H I
Department of Medical Oncology, BC Cancer Agency, Vancouver, Canada
Janssen Research & Development, San Diego.
Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18.
Few prognostic models for overall survival (OS) are available for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with recently approved agents. We developed a prognostic index model using readily available clinical and laboratory factors from a phase III trial of abiraterone acetate (hereafter abiraterone) in combination with prednisone in post-docetaxel mCRPC.
Baseline data were available from 762 patients treated with abiraterone-prednisone. Factors were assessed for association with OS through a univariate Cox model and used in a multivariate Cox model with a stepwise procedure to identify those of significance. Data were validated using an independent, external, population-based cohort.
Six risk factors individually associated with poor prognosis were included in the final model: lactate dehydrogenase > upper limit of normal (ULN) [hazard ratio (HR) = 2.31], Eastern Cooperative Oncology Group performance status of 2 (HR = 2.19), presence of liver metastases (HR = 2.00), albumin ≤4 g/dl (HR = 1.54), alkaline phosphatase > ULN (HR = 1.38) and time from start of initial androgen-deprivation therapy to start of treatment ≤36 months (HR = 1.30). Patients were categorized into good (n = 369, 46%), intermediate (n = 321, 40%) and poor (n = 107, 13%) prognosis groups based on the number of risk factors and relative HRs. The C-index was 0.70 ± 0.014. The model was validated by the external dataset (n = 286).
This analysis identified six factors used to model survival in mCRPC and categorized patients into three distinct risk groups. Prognostic stratification with this model could assist clinical practice decisions for follow-up and monitoring, and may aid in clinical trial design.
NCT00638690.
对于接受近期获批药物治疗的转移性去势抵抗性前列腺癌（mCRPC）患者，几乎没有总生存期（OS）的预后模型。我们利用醋酸阿比特龙（以下简称阿比特龙）联合泼尼松用于多西他赛后mCRPC的III期试验中易于获得的临床和实验室因素，开发了一种预后指数模型。
有762例接受阿比特龙-泼尼松治疗患者的基线数据。通过单变量Cox模型评估各因素与OS的相关性，并用于多变量Cox模型中采用逐步法确定有意义的因素。使用独立的、基于人群的外部队列对数据进行验证。
最终模型纳入了6个个体与预后不良相关的危险因素：乳酸脱氢酶>正常上限（ULN）[风险比（HR）=2.31]、东部肿瘤协作组体能状态为2（HR=2.19）、存在肝转移（HR=2.00）、白蛋白≤4g/dl（HR=1.54）、碱性磷酸酶>ULN（HR=1.38）以及从初始雄激素剥夺治疗开始至治疗开始的时间≤36个月（HR=1.30）。根据危险因素数量和相对HRs，将患者分为预后良好组（n=369，46%）、中等组（n=321，40%）和不良组（n=107，13%）。C指数为0.70±0.014。该模型经外部数据集（n=286）验证。
本分析确定了6个用于mCRPC生存建模的因素，并将患者分为3个不同的风险组。使用该模型进行预后分层可协助临床实践中关于随访和监测的决策，并可能有助于临床试验设计。
NCT00638690。
